BEUDAMED
    14 results · 23ms · Sources: EU EUDAMED, US FDA

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    PREXION 3D

    FDA 510(k)
    FDA Class 2 ·Radiology

    ArgenPMMA Multi 98x12-C2

    FDA UDI
    ARGEN CORPORATION, THE·D818120948·Crown And Bridge, Temporary, Resin

    WeightRight®

    FDA UDI
    DIVERSATEK HEALTHCARE, INC.·00816734020876·Tungsten-Filled Hurst Esophageal Dilator, 48 Fr...

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450321188·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450313091·

    SMITH & NEPHEW SURETAC - EXPANDED INDICATIONS II

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HYPO CLENZ WOUND WASH MODEL 100 PPM

    FDA 510(k)
    FDA Unclassified ·Unknown

    HAHN TAPERED IMPLANT Ø5.0 X 10 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·July 10, 2024

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 16, 2025

    INTERSTIM

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·May 20, 2013

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SHERBROOKE·Product code FPA·June 13, 2011

    IN TOUCH

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL QUEBEC LP·Product code FNL·August 13, 2008

    Baylis Medical TorFlex Transseptal Guiding Sheath, Rx Only, non-pyrogenic, sterile. Product Usage: The TorFlex Transseptal Guiding Sheath kit (K102948) is a single use device consisting of three components: a sheath, a dilator, and a J-tipped guidewire. The kit is designed for safe and easy catheterization and angiography of specific heart chambers and locations.

    FDA Recall
    Terminated ·Baylis Medical Corp 5959 TransCanada Highway Montreal Canada·Product code DYB·September 23, 2013

    Baylis Medical TorFlex Transseptal Guiding Sheath, Rx Only, non-pyrogenic, sterile. Product Usage: The TorFlex Transseptal Guiding Sheath kit (K102948) is a single use device consisting of three components: a sheath, a dilator, and a J-tipped guidewire. The kit is designed for safe and easy catheterization and angiography of specific heart chambers and locations.

    FDA Enforcement
    Class I ·Terminated·Baylis Medical Corp *·November 13, 2013